Real Life Clinical Effectiveness of Razumab® (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration: A Subgroup Analysis of Pooled Retrospective RE-ENACT Study

Background: This subgroup analysis of RE-ENACT study (retrospective, multicenter, observational pooled study on wet age-related macular degeneration [wet AMD], diabetic macular edema, and retinal vein occlusion) evaluated the effectiveness of Razumab® (world's first biosimilar ranibizumab by Intas Pharmaceuticals Ltd., India) in Indian patients with wet AMD. Methods: Data of the patients with wet AMD, who were treated with ≥3 injections of Razumab® between January and August 2016, were included. Endpoints were: improvement in best corrected visual acuity (BCVA, measured by logMAR/Snellen's chart), decrease in central macular thickness (CMT, measured by Spectral Domain Optical Coherence Tomography), and intraretinal fluid (IRF) and subretinal fluid (SRF) from baseline at Weeks 4, 8 and 12. Result: Medical charts of 194 patients were analysed; 112 (57.73%) were men, 82 (42.27%) were women. Mean ± SE BCVA improved from baseline (0.81 ± 0.03) at Week 4 (0.78 ± 0.03; p=0.13) and attained significance at Weeks 8 (0.66 ± 0.02) and 12 (0.55 ± 0.02; p<0.0001 for both time points); mean ± SE CMT significantly decreased from baseline (393.02 ± 7.32 μm) to Weeks 4 (385.93 ± 7.10 μm; p=0.0041), 8 (332.75 ± 6.10 μm; p<0.0001) and 12 (293.5 ± 4.10 μm; p<0.0001). Proportion of patients with IRF and SRF significantly (P<0.0001) decreased from baseline to Weeks 4, 8 and 12 (59.79% vs. 47.94%, 41.75%, and 31.96%, respectively for IRF; and 82.47% vs. 66.49%, 51.03%, 41.24%, respectively for SRF). No new safety concerns with biosimilar ranibizumab were observed. Conclusion: Razumab® (biosimilar ranibizumab) effectively improved the visual acuity and disease outcomes with no new safety concerns in patients with wet age-related macular degeneration in the real world setting.